Empagliflozin is associated with a reduced risk of cardiovascular death or hospitalization for heart failure (HF) in HF patients with a reduced ejection fraction, according to new data from the EMPEROR-Reduced trial.
The findings were presented at ESC Congress 2020 and published in the New England Journal of Medicine.
The EMPEROR-Reduced trial included data from more than 3,700 adult patients with HF and a left ventricular ejection fraction of 40% or less. Patients randomly received either empagliflozin treatment or a placebo, and 49.8% had a history of diabetes.
The EMPEROR-Reduced trial’s primary endpoint was the composite of cardiovascular death or hospitalization related to HF. Its secondary endpoints were adverse renal outcomes. During a median follow-up period of 16 months, that primary endpoint occurred 361 times in patients from the group that received empagliflozin and 462 in the group that received a placebo. Renal outcomes occurred in 30 patients from the empagliflozin group and 58 patients from the placebo group.
“Empagliflozin reduced the risk of serious HF events by 30% and decreased the risk of serious adverse renal outcomes by 50%,” lead author Milton Packer, MD, Baylor University Medical Center in Dallas, said in a statement. “This trial extends the benefits of sodium–glucose cotransporter 2 (SGLT2) inhibitors to higher-risk patients and shows a meaningful benefit on renal outcomes in patients with HF for the first time.”
Packer and colleagues also looked deeper at key differences—and similarities—between the two groups.
“Uncomplicated genital tract infection was reported more frequently in the empagliflozin group,” they wrote. “The frequency of hypoglycemia, lower limb amputation, and bone fracture did not differ between the two groups, even though these adverse events have been associated with the use of certain SGLT2 inhibitors in trials involving patients with type 2 diabetes. Safety concerns that have been seen with other drugs for HF (e.g., hypotension, volume depletion, renal dysfunction, bradycardia, and hyperkalemia) were not evident with empagliflozin in the current trial.”
Overall, the team concluded, “empagliflozin was associated with a lower combined risk of cardiovascular death or hospitalization for HF than placebo and with a slower progressive decline in renal function in patients with chronic heart failure and a reduced ejection fraction, regardless of the presence or absence of diabetes.”
The full New England Journal of Medicine analysis of the EMPEROR-Reduced trial can be read here.
ESC Congress 2020 is completely digital due to the ongoing COVID-19 pandemic. More information from the European Society of Cardiology is available here.